The present invention relates to an improved snuff useful in the nasal application of nicotine. The invention pertains to a rapid, pleasant and harmless mixture containing nicotine for nasal application which is absorbed by the nasal membranes. The invention further pertains to a method for preparing an improved snuff useful in the nasal application of nicotine.
Tobacco has been used for hundreds of years by many cultures throughout the world. Currently popular methods of use include smoking tobacco, such as in cigarettes, cigars or a pipe, chewing and sniffing. However, these methods have numerous disadvantages, including inherent health hazards and social unacceptability.
Medical research has established that nicotine is the active ingredient in tobacco. Small doses of nicotine provide the user with certain pleasurable effects resulting in the desire for additional doses. However, recent medical research published by Russell et al, Nasal Nicotine Solution: A Potential Aid to Giving Up Smoking?, British Medical Journal, vol. 286, p. 683 (Feb. 26, 1983), indicates that nicotine is not a carcinogen. There is also evidence that nicotine is not responsible for the high rate of death among cigarette smokers. For example, see Wald, N. J. et al, Serum Cotinine Levels in Pipe Smokers: Evidence Against Nicotine As Cause of Coronary Heart Disease, The Lancet, Oct. 10, 1981, p. 775. Thus, one who uses tobacco for the pleasurable effects of nicotine must also risk the dangers of coronary heart disease and cancer although there is speculation that such adverse side effects are in fact the result of naturally occurring tobacco components and of the by-products of combustion normally associated with the smoking habit.
Several techniques have been developed which allow the body to absorb small amounts of uncontaminated nicotine. These include nicotine chewing gum, nicotine tablets and nicotine vapor inhalants. There is evidence, however, that the degree of pleasure derived from nicotine is proportional to how rapidly the nicotine enters the blood stream of the user. Russell, Nicotine Intake and Its Regulation, Journal of Psychosomatic Research, Vol. 24, p. 253 (December, 1979). When nicotine is administered orally, it is absorbed by the lining of the mouth which is a relatively slow process. The inhalation of nicotine vapor allows nicotine to enter the body almost instantaneously through the lining of the lungs, but the manufacturing and packaging costs of such devices are relatively high compared to the subject invention.
On the other hand, the nasal administration of nicotine allows the absorption of the substance to occur approximately as rapidly as by inhalation. Russell et al., A New Age for Snuff?, The Lancet, Mar. 1, 1980, p. 474; Russell et al., Nicotine Intake by Snuff Users, British Medical Journal, Vol. 283, p. 814 (Sept. 26, 1981). Conventional nasal snuff, however, offers several disadvantages to the user. Because it is finely ground leaf material, its most significant drawback is that it is not water soluble and tends to form a brown, offensive coating on the inside of the user's nasal passages. Furthermore, because of the carcinogens found in tobacco, the use of snuff carries at least a slight risk of nasal cancer.
Recently, a liquid nasal nicotine solution has been developed by Russell et al, Nasal Nicotine Solution: A Potential Aid to Giving Up Smoking?, British Medical Journal, Vol. 286 at page 683 (Feb. 26, 1980). A two percent aqueous solution of nicotine was combined with a cellulose derivative to increase its viscosity and allow the mixture to remain in the user's nasal passages. Each dosage (0.1 milliter) was made up in a small plastic container which could be opened and squeezed for administration. The nasal solution has the disadvantages of being expensive to manufacture and inconvenient to use, requiring a conventional snuff user to change his established ritual.
Other methods of application of nicotine have developed a social acceptability. Examples of these are the oral use of so-called smokeless tobacco, some of which is contained in a porous pouch.
For the most part, the prior art has involved the development of various application devices as opposed to actual nicotine formulas. Examples of such devices which are known include: U S. Pat. No. 2,809,634 to Murai (pipe device used to atomize a material in solution which is inhaled); U.S. Pat. No. 4,192,309 to Poulsen (breath actuated inhalation device for dispensing a powdered medicament through the mouth or nasal cavity); U.S. Pat. No. 4,203,454 to Wutscher (an elaborate device for projecting snuff into the nostrils); U.S. Pat. No. 1,599,787 to Perkins (apparatus for nasal douche); and U.S. Pat. No. 2,496,125 to Griesman (nasal applicator device).